Mucinex generics — when can they launch?
Mucinex (guaifenesin) · Generic (multiple manufacturers) · 3 active US patents · 0 expired
Where Mucinex sits in the generic timeline
Long-dated protection: earliest active US patent for Mucinex extends to 2035 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 3 patents
FDA U-codes carved out by Mucinex patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2023 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Mucinex drug page →
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This patent protects a method of treating or ameliorating a condition with an immediate release oral guaifenesin solution that includes propylene glycol and glycerol as solvents.USPTO title: Immediate release oral guaifenesin solution
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This patent protects an immediate release oral solution for guaifenesin that includes propylene glycol and glycerol as solvents to increase guaifenesin bioavailability.USPTO title: Immediate release oral guaifenesin solution
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This patent protects an immediate release oral solution for guaifenesin that includes propylene glycol and glycerol as solvents to increase guaifenesin bioavailability.USPTO title: Immediate release oral guaifenesin solution
Sources
- FDA Orange Book — patents listed against Mucinex (NDA filed 1952)
- Mucinex drug profile — full patent estate, indications, clinical trials, pricing
- Generic (multiple manufacturers) patent portfolio
- Patent cliff 2035 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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